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vismodegib

Erivedge · ATC code L01XX43

Key facts
Active substance
vismodegib
ATC code
L01XX43
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Erivedge 150 mg hard capsules
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-29

Key facts

Vismodegib is a Hedgehog pathway inhibitor. It is used in adults with metastatic or locally advanced basal cell carcinoma when surgery or radiotherapy is inappropriate.

What it is used for

  • Adults with symptomatic metastatic basal cell carcinoma (Erivedge).
  • Adults with locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy.

Dosing

  • Erivedge 150 mg hard capsules: one capsule once daily, swallowed whole with water, with or without food; capsules must not be opened.
  • Missed dose: do not take it; resume with the next scheduled dose.
  • In studies, treatment continued until progression or unacceptable toxicity; interruptions of up to 4 weeks were allowed.
  • No dose adjustment in the elderly, mild to moderate renal impairment or hepatic impairment; monitor carefully in severe renal impairment.
  • Should not be used in children and adolescents under 18 years.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Women who are pregnant or breast-feeding.
  • Women of childbearing potential who do not comply with the Pregnancy Prevention Programme.
  • Co-administration of St John's wort.

Important warnings

  • May cause embryo-foetal death or severe birth defects; strict Pregnancy Prevention Programme.
  • Women of childbearing potential: two contraceptive methods (one highly effective plus a barrier method) during treatment and for 24 months after the final dose.
  • Men: always use a condom during treatment and for 2 months after the final dose; no semen donation for 2 months.
  • No blood donation during treatment and for 24 months after the final dose.
  • Severe cutaneous reactions (SJS/TEN, DRESS, AGEP) may occur; premature epiphyseal closure in children.

Side effects

  • In ≥ 30% of patients: muscle spasms (74.6%), alopecia (65.9%), dysgeusia (58.7%), weight decreased (50.0%), fatigue (47.1%), nausea (34.8%) and diarrhoea (33.3%).

Interactions

  • Avoid strong CYP inducers (e.g. rifampicin, carbamazepine, phenytoin); St John's wort is contraindicated.
  • Clinically significant interactions with pH-elevating agents or CYP450 inhibitors are not expected.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy and breast-feeding; women must not become pregnant during treatment and for 24 months after the final dose.
  • If a period is missed or pregnancy is suspected, the treating physician must be informed immediately.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ErivedgeRoche Registration GmbH · EMEA/H/C/002602

Source: European Medicines Agency (EMA), product information

Turkey

  • ErigibDEVA HOLDİNG A.Ş. · 1 register entry
  • ErivedgeROCHE MÜSTAHZARLARI SAN.A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Erivedge
Liechtenstein
Erivedge
Norway
Erivedge

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Erivedge – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.